DEN210037
- 510(k) number
- DEN210037
- Device name
- SoClean 3+ Bacterial Reduction Device
- Applicant
- Soclean, Inc. NH · US
- Product code
- QXQ — Respiratory Accessory Microbial Reduction Device.
- Decision date
- 2024-08-12
- Date received
- 2021-09-15
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General Hospital
Official FDA record: DEN210037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.